Implantable penile prosthesis pump

ABSTRACT

Pumps for use with inflatable implantable penile prostheses in accordance with the invention include features that can provide for free fluid flow during inflation and deflation modes of the pump. Pumps may also include a bypass chamber that is fluidly connected to the fluid passageway by a bypass input channel and a bypass output channel. The bypass chamber comprises a bypass check valve biased toward a closed position.

REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 11/305,672, filed Dec. 16, 2005 now U.S. Pat. No. 7,637,861, whichclaims the benefit of U.S. provisional patent application No.60/637,032, filed Dec. 17, 2004, entitled “Side Squeeze MomentarySqueeze Pump,” the entire disclosures of which are incorporated hereinby reference for all purposes.

TECHNICAL FIELD

The invention relates to systems for treating erectile dysfunction andother urological disorders. In particular, the invention relates topumps for use with inflatable implantable penile prostheses.

BACKGROUND

One common treatment for male erectile dysfunction is the implantationof a penile prosthesis. Such a prosthesis typically includes a pair ofinflatable cylinders, which are fluidly connected to a reservoir via apump and valve assembly. The two cylinders are normally implanted intothe corpus cavernosae of the patient and the reservoir is typicallyimplanted into the patient's abdomen. The pump assembly is implanted inthe scrotum.

During use, the patient actuates the pump and fluid is transferred fromthe reservoir through the pump and into the cylinders. This results inthe inflation of the cylinders and thereby produces the desired penisrigidity for a normal erection. Then, when the patient desires todeflate the cylinders, a valve assembly within the pump is actuated in amanner such that the fluid in the cylinders is released back into thereservoir. This deflation then returns the penis to a flaccid state.

Presently, the pump and valve assembly used in such implantableprostheses share certain similar characteristics. For example, theyinclude fluid pathways allowing the flow of fluid to and from thereservoir, as well as to and from the cylinders. In some designs thisfluid flow is controlled by one or more poppet valves positioned in suchfluid pathways within the housing of the assembly.

A compressible pump bulb is also attached to the housing and is in fluidcommunication with the various fluid pathways. In order to inflate thecylinders, the compressible pump bulb is actuated by the patient,thereby urging fluid in the bulb past the poppet valves into thecylinders. In order to deflate the cylinders, the valve housing isgrasped and squeezed, through the patient's tissue, causing the variouspoppet valves to unseat and allow fluid to flow back to the reservoir.

SUMMARY

Pumps for use with inflatable penile prostheses in accordance with theinvention can be designed to include advantageous features such as theability to functionally arrange valve components in a compact manner anddifferent alignment between functional valve components.

In one aspect of the invention, a pump that provides a feature thatallows a free path for fluid flow under certain conditions is provided.The pump preferably comprises a pump housing, first and second fluidports, and a pump bulb. The pump housing comprises a fluid passageway.The first and second fluid ports are in fluid communication with thefluid passageway and are operatively connectable to a fluid reservoirand at least one inflatable penile prosthesis, respectively. The pumpbulb is in fluid communication with the fluid passageway and can beoperated to transfer fluid between the first and second fluid portsthrough the fluid passageway. The pump comprises a poppet positionedwithin the fluid passageway. The poppet includes an extending portionextending away from a body portion of the poppet. The extending portionhas a sealing surface biased toward a valve seat within the fluidpassageway. The pump includes a flange extending from a surface of thefluid passageway and toward the interior of the fluid passageway andspaced from the valve seat within the fluid passageway. One or more ofthe flange and the extending portion of the poppet may include one ormore protrusions that provide a gap between the flange and extendingportion of the poppet. In one embodiment of a refill phase of pumping, afluid path is established between the extending portion of the poppetand the flange when the extending portion of the poppet is in contactwith the flange so that fluid can pass from one side of the flange tothe other.

In another aspect of the invention, a pump with slidingly engagedpoppets is provided. The pump preferably comprises a pump housing, firstand second fluid ports, and a pump bulb. The pump housing comprises afluid passageway. The first and second fluid ports are in fluidcommunication with the fluid passageway and are operatively connectableto a fluid reservoir and at least one inflatable penile prosthesis,respectively. The pump bulb is in fluid communication with the fluidpassageway and can be operated to transfer fluid between the first andsecond fluid ports through the fluid passageway. The pump includes firstand second poppets positioned within the fluid passageway and biasedtoward first and second valve seats within the fluid passageway,respectively. The first poppet comprises an end slidingly engaged withan end of the second poppet.

In yet another aspect of the invention a pump having a bypass chamber isprovided. The pump preferably comprises a pump housing, first and secondfluid ports, and a pump bulb. The pump housing comprises a fluidpassageway. The first and second fluid ports are in fluid communicationwith the fluid passageway and are operatively connectable to a fluidreservoir and at least one inflatable penile prosthesis, respectively.The pump bulb is in fluid communication with the fluid passageway andcan be operated to transfer fluid between the first and second fluidports through the fluid passageway. First and second poppets arepositioned within the fluid passageway, aligned along a poppet valveaxis, and biased toward first and second valve seats within the fluidpassageway, respectively. The bypass chamber is fluidly connected by abypass input channel to the fluid passageway at a first location andfluidly connected by a bypass output channel to the fluid passageway ata second location. The bypass chamber comprises a bypass check valvebiased toward a closed position along a check valve axis. The checkvalve axis is oriented in a non-parallel manner with respect to thevalve axis of the first and second poppets.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be further explained with reference to the appendedFigures, wherein like structure is referred to by like numeralsthroughout the several views, and wherein:

FIG. 1 is a perspective view of a pump assembly that can be used with aninflatable implantable penile prostheses in accordance with theinvention;

FIG. 2 is a side view of the pump assembly illustrated in FIG. 1;

FIG. 3 is bottom view of the pump assembly illustrated in FIG. 1;

FIG. 4 is a cross-sectional view of the pump assembly illustrated inFIG. 3, taken along the line 4-4;

FIG. 5 is a cross-sectional view of the pump assembly illustrated inFIG. 4, taken along the line 5-5;

FIG. 6 is a cross-sectional view of the pump assembly illustrated inFIG. 2, taken along the line 6-6;

FIG. 7 is a cross-sectional view of the pump assembly illustrated inFIG. 4, taken along the line 7-7;

FIG. 8 is a cross-sectional view of the pump assembly illustrated inFIG. 5, taken along the line 8-8;

FIG. 9 is a cross-sectional view of the pump assembly illustrated inFIG. 5, taken along the line 9-9;

FIG. 10 is a cross-sectional view of another embodiment of a pumpassembly of the invention;

FIG. 11 is a cross-sectional view of the pump assembly of FIG. 10 takenalong the line 11-11;

FIG. 12 illustrates a schematic perspective view of an implantablepenile prosthesis device having a pump assembly of the type illustratedin FIGS. 1 through 11; and

FIG. 13 is another cross-sectional view of the pump assembly illustratedin FIG. 6, with the internal components configured in a differentoperating condition of the pump.

DETAILED DESCRIPTION

Referring to FIGS. 1 through 9 and 13, pump assembly 10 for use in animplantable penile prosthesis system is illustrated. In FIGS. 1 through3, a perspective, side, and bottom view of the pump assembly 10 areshown, respectively. In FIGS. 4 through 9 and 13, variouscross-sectional views of the pump assembly 10 are shown to illustrateits various functional aspects and components. In general, when a penileprosthesis system is implanted into a person, a pump assembly, such aspump assembly 10, is positioned within the user's scrotum, twoinflatable cylinders are positioned within the user's corpus cavernosaeand a reservoir is implanted in the user's abdomen. One or more tubesprovide fluid communication between assembly 10 and the cylinders andbetween assembly 10 and the reservoir. In this embodiment, assembly 10includes housing or pump body 12 connected to pump bulb 14 having aninternal chamber 16. Pump assembly 10 is connected for fluidcommunication with at least one inflatable cylinder (not shown) by ports20 and 21, which preferably comprise flexible silicone tubes.Alternatively, pump assembly 10 can be designed with a single port thatcomprises a single tube that could be fluidly connected directly to pumpassembly 10 and branch into multiple tubes that extend to each of thecylinders at some distance from pump assembly 10. Any such tube ispreferably relatively flexible for comfort and conformability within apatient, and may have a constant or varying (e.g., tapered) diameteralong its length.

Pump assembly 10 is further connected for fluid communication with atleast one fluid-filled reservoir (not shown) by at least one reservoirport 18 that preferably comprises a flexible silicone tube as shown.While only one port is used in the embodiment shown in FIG. 1, assembly10 may include additional ports for connection to one or morereservoirs, or a single port may be fluidly connected to pump assembly10 with a tube that branches into multiple tubes that connect to one ormore reservoirs. In the preferred embodiment, however, port 18 isprovided to fluidly connect pump assembly 10 to a single reservoir,which is typically implanted in the abdomen or some other location inthe user's body that is spaced from pump assembly 10. Any such tube usedwith port 18 is preferably made of a relatively flexible material, suchas silicone, and is sufficiently long for connecting the reservoir tothe pump body when these components are implanted in their desiredlocations in the body.

Pump assembly 10 of the invention is controllable by the user to movefluid to and from the inflatable cylinders, as desired. Importantly,pump assembly 10 preferably includes features that can eliminate orreduce the possibility of a vacuum lock that can interrupt the inflationprocess as described in more detail below. Preferably, pump assembly 10also includes poppets that slidingly engage to provide an alignmentfeature for such poppets in the pump assembly. In addition, pumpassembly 10 is preferably configured so that poppet valve components ofpump assembly 10 are provided along a short axis of pump body 12. Inthis way, a stable platform for the user's fingers to hold onto the pumpassembly and squeeze for deflation is provided. Thus, pump assembly 10provides a reliable controllable device that is easily manipulated bythe user to inflate and deflate the cylinders, as desired.

Pump body 12 preferably comprises a generally flexible device thatincludes a number of components to provide the desired movement of fluidthrough its internal chambers. Reservoir port 18 is fluidly connected totransfer chamber 22 within pump body 12. As can be seen best in thesection view of FIG. 8, transfer chamber 22 is fluidly connected toannular channel 68 and radial channels 70, 72, and 74. Transfer chamber22 can also fluidly communicate with ports 20 and 21 through connectingfluid passageway 24 (see FIGS. 4 and 5, for example). Fluid passageway24 is further connected to internal chamber 16 of pump bulb 14 byconnecting channel 26 (see FIG. 5), where the various fluidicconnections can be initiated and terminated with the operation of pumpassembly 10, as described below. As shown in FIG. 6, for example, fluidpassageway 24 is a generally elongated chamber that extends across aportion of width 25 of pump body 12 and provides a passageway throughwhich fluid can flow between the components of pump assembly 10, such asa reservoir, internal chamber 16, fluid bypass chamber 46, andcylinders.

Referring particularly to FIG. 6, fluid passageway 24 includes withinits internal area a check valve system that generally includes reservoirpoppet 28 and cylinder poppet 36. Reservoir poppet 28 and cylinderpoppet 36 are preferably coaxially aligned with each other on a poppetvalve axis 23 along the length of passageway 24, with both poppetspreferably being centrally positioned within passageway 24. Reservoirpoppet 28 has a generally elongated shape and is designed for contactand sealing with various components of the system during its operation.In particular, reservoir poppet 28 includes elongated body 29 that ispreferably generally cylindrical, as shown, although it can take anynumber of shapes that fit within the internal chamber of fluidpassageway 24 to provide contact with its surfaces and control themovement of fluid. Reservoir poppet 28 further includes face sealportion 30 that is preferably a ring-like protrusion that extends aroundthe outer perimeter of elongated body 29. As shown, face seal portion 30is positioned near the center of the length of elongated body 29,although it is possible that portion 30 is closer to one of the ends ofelongated body 29 than its other end. Face seal portion 30 includes asealing surface 33 for providing a seal with a surface 35 of valve seat34 when pump assembly 10 is configured for filling of an implantablecylinder. Face seal portion 30 also includes chamfer 31 for providing aseal with flange 44 when pump assembly 10 is configured for deflation ofan implantable cylinder. Surface 35 of valve seat 34 that contactssurface 33 of face seal portion 30 is preferably a generally smoothsurface that allows for a fluid tight seal between surface 33 of faceseal portion 30 and surface 35 of valve seat 34, when such sealing isdesired. A spring 32 engages reservoir poppet 28 and biases reservoirpoppet 28 toward valve seat 34.

Fluid passageway 24 further includes flange 44 configured generally as aring-like portion within passageway 24 that preferably extends towardthe center of passageway 24 around the inner perimeter of fluidpassageway 24. Flange 44 is provided to reduce the inner diameter ofpassageway 24 by a sufficient amount so that the inner diameter in thearea of flange 44 is smaller than the outer diameter of face sealportion 30. In this way, flange 44 can engage with chamfer 31 to holdreservoir poppet 28 against the bias of spring 32. Flange 44 preferablyhas sufficient strength to hold face seal portion 30 against the bias ofspring 32, but also is flexible enough to allow movement of face sealportion 30 through or past flange 44 in either direction (i.e., to theright or left with respect to FIG. 5). Flange 44 may be annular andextend around the inner perimeter of passageway 24, as shown, or mayinstead have a different shape or configuration that can provide thefunction of engaging and disengaging sufficiently with face seal portion30 in the manner described above. Further, flange 44 may be formedintegrally with passageway 24 or may be formed separately and attachedto the interior of passageway 24, such as with adhesives or the like.Spring 32 preferably has sufficient spring force to provide the desiredamount of sealing between face seal portion 30 and valve seat 34 whenface seal portion 30 is above flange 44 with respect to FIG. 6 (see FIG.13, for example). Spring 32 should not be so strong, however, that itpushes reservoir poppet 28 past flange 44 toward valve seat 34 when itis instead desired for face seal portion 30 to be on the opposite sideof flange 44.

Fluid passageway 24 also includes within its internal area a poppetvalve seat 40 having sealing surface 41 adjacent to cylinder poppet 36.Cylinder poppet 36 includes face seal portion 37 that is preferably aring-like protrusion that extends around the outer perimeter of cylinderpoppet 36. Face seal portion 37 includes a sealing surface 39 forproviding a seal with surface 41 of valve seat 40. Surface 41 of valveseat 40 that comes into contact with surface 39 of face seal portion 37is preferably a generally smooth surface that allows for a fluid tightseal between surface 39 of face seal portion 37 and surface 41 of valveseat 40, when such sealing is desired.

In FIG. 13, pump assembly 10 is shown in a configuration where sealingsurface 39 of poppet face seal portion 37 contacts sealing surface 41 ofpoppet valve seat 40 to provide a fluid tight seal. Poppet spring 38engages cylinder poppet 36 and biases cylinder poppet 36 toward valveseat 40. Poppet spring 38 is preferably strong enough to provide a fluidtight seal between sealing surface 39 of poppet face seal portion 37 andsealing surface 41 of valve seat 40. Spring 38 is preferably not sostrong that the cylinder poppet 36 is prevented from being moved back toits position shown in FIGS. 5 and 6. Such a movement of cylinder poppet36 away from valve seat 40 allows fluid to pass from fluid passageway 24into ports 20 and 21 during operation of pump assembly 10.

The internal area or portion of fluid passageway 24 further includes alip seal 42 that extends generally from the area between valve seat 40and flange 44. In one preferred embodiment, lip seal 42 may be generallyconical in shape such that it tapers from a first cross-section in thepump body to a point or edge at its other end. This lip seal 42 is shownin cross-section in FIG. 6 as a finger-like portion that extends intofluid passageway 24. It is contemplated, however, that lip seal 42 has adifferent configuration or shape for sealing against the outside surfaceof reservoir poppet 28. Lip seal 42 is preferably configured so that itcan contact the outer surface of reservoir poppet 28 and provide a fluidtight seal between lip seal 42 and reservoir poppet 28 when reservoirpoppet 28 is positioned with face seal portion 30 out of contact withvalve seat 34, and with chamfer 31 in contact with flange 44. Lip seal42 is preferably further configured to allow smooth movement ofreservoir poppet 28 into and out of contact with lip seal 42. However,lip seal 42 will be spaced from the outer surface of reservoir poppet 28when the portion of reservoir poppet 28 that is adjacent to lip seal 42is smaller in diameter than lip seal 42. This will occur, for example,when reservoir poppet 28 is moved so that face seal portion 30 is incontact with valve seat 34. In this mode, fluid would then be able tomove through fluid passageway 24 and past lip seal 42.

As illustrated in FIG. 6, cylinder poppet 36 includes receiver 48 thatis designed to slidingly engage with nose portion 50 of reservoir poppet28. As shown, receiver 48 provides an opening or hole that can receiveand engage with nose portion 50. Such engagement between nose portion 50and receiver 48 helps to maintain coaxial alignment of reservoir poppet28 and cylinder poppet 36 in pump body 12 and throughout the range oftravel of reservoir poppet 28 and cylinder poppet 36. Nose portion 50and reservoir poppet 28 can be designed in any manner that provides atleast some overlapping sliding engagement between reservoir poppet 28and cylinder poppet 36 for providing an aligning function between thesecomponents. When reservoir poppet 28 is moved away from valve seat 34 sothat chamfer 31 is engaged with flange 44 against the bias of spring 32,nose portion 50 of reservoir poppet 28 can slide within and push againstan inside end surface of receiver 48 of cylinder poppet 36 against thebias of poppet spring 38, thereby allowing for a certain fluid flowpath. Thus, it is also preferable that poppet spring 38 and spring 32are chosen to provide the desired ease of movement of components. Thatis, undue force should not be required to move the springs and poppetsthrough the various operation modes of pump assembly 10. In particular,it is required for operation of pump assembly 10 that the sides of pumpbody 12 are compressible to thereby manipulate the position of reservoirpoppet 28 and cylinder poppet 36 relative to each other and pump body12. In order for this to be possible, it is preferable that reservoirpoppet 28 is in sufficiently close proximity to the side of pump body 12so that squeezing pump body 12 with a reasonable amount of force willmove reservoir poppet 28 within pump body 12 into certain positions.

Pump body 12 further includes fluid bypass chamber 46 that is connectedfor fluid communication with fluid passageway 24 under certain operatingconditions or modes of pump assembly 10. Fluid bypass chamber 46includes ball check valve 54 having ball 56 and spring 58. Spring 58biases ball 56 within chamber 46 along a check valve axis 27 toward ballvalve seat 52, which is a portion or edges of chamber 46 that form adiameter that is smaller than the diameter of ball 56. In this way, afluid tight seal may be formed between ball 56 and ball valve seat 52when the system is in a state of equilibrium or when there is fluidpressure in chamber 64. This seal prevents the undesired movement offluid through bypass chamber 46 except under certain operatingconditions of pump assembly 10. As with the other springs used in pumpassembly 10, spring 58 should be sufficiently strong to keep ball 56 inits normal or closed position against ball valve seat 52 under certainoperating circumstances. However, spring 58 should also allow for apredetermined flow of fluid against the bias of spring 58 to move theball 56 out of contact with ball valve seat 52 to allow fluid to flowthrough bypass chamber 46. As shown, fluid may move from fluidpassageway 24 into bypass chamber 46 through a bypass input channel 62during a deflation configuration of pump assembly 10.

When there is a sufficient pressure in combination with sufficientvolume of pressurized fluid in chamber 46 to move ball 56 against thebias of spring 58, the fluid will be able to move freely from inputchannel 62 and through bypass chamber 46. Fluid may then exit bypasschamber 46 through bypass output channel 64 that provides a second fluidconnection between bypass chamber 46 and fluid passageway 24. Bypassoutput channel 64 is positioned with respect to lip seal 42 so thatcertain operating conditions will provide a fluid path in which fluidpasses by reservoir poppet 28 and enters transfer chamber 22. The valvestyle used in fluid bypass chamber 46 of FIG. 1 is shown as a ball checkvalve, but it could instead include any number of designs such as a“duck bill valve”, flap, or the like, which react to pressurized fluidin generally the same manner as the ball check valve 54.

In order to provide a compact design, the check valve axis 27 as definedby bias direction of spring 58 is preferably provided at an anglegreater than zero degrees (non-parallel) to the poppet valve axis 23 ofreservoir poppet 28 and cylinder poppet 36. If the check valve axis 27and poppet valve axis 23 are generally parallel, bypass input chamber 62and bypass output chamber 64 would be spaced further apart than inconfigurations where the check valve axis 27 is at an angle to thepoppet valve axis 23 in order to accommodate the check valve 54. Thiswould have the effect of increasing width 25 of pump body 12. In thearrangement where the check valve axis 27 and poppet valve axis 23 aregenerally perpendicular, bypass input chamber 62 and bypass outputchamber 64 are closer together such that the width 25 of pump body 12can be at least slightly smaller.

The components of pump assembly 10 can be positioned in a configurationthat provides an auto-inflation resistance mode. In this mode, thecylinders are in a deflated condition and spontaneous inflation of thecylinders will preferably be difficult or impossible due to thepositions of the poppets, springs and chambers of pump assembly 10. Noinflation of the cylinders can occur until pump bulb 14 is manipulatedin a specified manner. In this mode, the fluid of the system willtypically be contained within reservoir port 18, transfer chamber 22,and the reservoir (not shown), and this fluid cannot travel into ports20 and 21 and the attached cylinders. In this mode, reservoir poppet 28is being held against the bias of spring 32 by flange 44 within fluidpassageway 24. Nose portion 50 of reservoir poppet 28 is engaged withthe receiver 48 of cylinder poppet 36 in a way that pushes cylinderpoppet 36 against the bias of poppet spring 38. Reservoir poppet 28 isthus positioned so that its outer surface is in contact with lip seal42, thereby creating a fluid-tight seal between reservoir poppet 28 andlip seal 42.

In most cases, some portion of the fluid from the reservoir will moveinto port 18 and transfer chamber 22, particularly when the reservoir isunder pressure. Any such pressurized fluid in transfer chamber 22 canmove into fluid passageway 24 and move reservoir poppet 28 slightlytoward cylinder poppet 36. This movement of reservoir poppet 28 allowsfluid to flow from transfer chamber 22 through a gap between face sealportion 30 and reservoir poppet valve seat 34. This fluid will thenenter internal chamber 16 through connecting channel 26. Movement offluid into chamber 16 of pump bulb 14 will stop when the pressure hasgenerally equalized between chamber 16 and the reservoir. The bias ofspring 32 can then move face seal portion 30 back into contact withvalve seat 34, thereby limiting or preventing further fluid flow intochamber 16.

Because lip seal 42 and reservoir poppet 28 form a fluid tight seal, asdescribed above, no fluid can move past this seal toward ports 20 and 21and connected cylinders. In addition, fluid attempting to move intofluid bypass chamber 46 through bypass output channel 64 will beprevented from moving past ball check valve 54 by the seal of ball 56against ball valve seat 52. Thus, no fluid will be able to pass intofluid passageway 24 or ports 20 and 21 by this path. In this state ofequilibrium, fluid will thus be held within the reservoir, connectingreservoir port 18, transfer chamber 22, annular channel 68, radialchannels 70, 72, and 74, as well as chamber 16. When the pump isconfigured in this mode, there may be small amounts of residual fluidcontained in the various portions of the pump assembly, and thecylinders will be partially or completely deflated or collapsed.

The components of pump assembly 10 can be positioned in a manner thatprovides an activation mode of pump assembly 10 for cylinder inflation.This is the mode in which the user activates pump assembly 10 to beginthe process of cylinder inflation. To activate pump assembly 10, pumpbulb 14 is squeezed or compressed by the user. This motion forces thefluid contained within pump chamber 16 through connecting channel 26 andinto fluid passageway 24 under relatively high fluid pressure. This highpressure fluid forces chamfer 31 of face seal portion 30 of reservoirpoppet 28 past flange 44, which flange is made of a material that isrelatively flexible to allow face seal portion 30 to move past it, yetsufficiently strong to hold reservoir poppet 28 against the bias ofspring 32. The bias of spring 32 will then push reservoir poppet 28 andface seal portion 30 against valve seat 34, thereby providing a fluidtight seal between face seal 30 and valve seat 34. Because the portionof reservoir poppet 28 adjacent lip seal 42 is now smaller in diameterthan the internal opening provided by lip seal 42, lip seal 42 is not incontact with reservoir poppet 28 in this mode (i.e., a gap is createdbetween reservoir poppet 28 and lip seal 42). Thus, fluid can move pastlip seal 42 and toward cylinder poppet 36. In order for fluid to movepast cylinder poppet 36 and into ports 20 and 21, however, the fluidpressure must be high enough to overcome the bias of poppet spring 38,which is now pushing cylinder poppet 36 in fluid tight contact withpoppet valve seat 40. The amount and pressure of the fluid may or maynot be sufficient to cause such a movement of cylinder poppet 36 in thispump activation mode.

Where the fluid pressure is sufficiently high to overcome the bias ofpoppet spring 38, fluid-tight contact between cylinder poppet 36 andpoppet valve seat 40 can be broken, thereby providing a gap betweensealing surface 39 of poppet face seal portion 37 and sealing surface 41of valve seat 40. This may be referred to as the pumping mode of pumpassembly 10. Fluid may then flow past lip seal 42 and cylinder poppet36, and then into ports 20 and 21 and the attached inflatable cylinders.In particular, after a first volume of pressurized fluid from pump bulbis moved past cylinder poppet 36 and into the cylinders (e.g., asdescribed above), the bias of poppet spring 38 will push cylinder poppet36 back into contact with poppet valve seat 40 to stop flow so that pumpbulb 14 can be refilled.

In the pump bulb filling mode, pump bulb 14 is pulling or drawing fluidfrom the reservoir and through the various chambers of the system. Pumpbulb 14 is preferably selected from a material that is relativelyelastic and easy for a user to compress, but should also have sufficientstructural integrity that it tends to move back toward its original sizeor configuration when not subjected to external pressure. That is, whenthe user releases pump bulb 14, it should expand generally to itsoriginal shape and size, thereby providing a situation where pump bulbchamber 16 and fluid passageway 24 are placed under negative pressure.This negative pressure provided by the expansion of pump bulb 14 willdraw fluid from the reservoir through reservoir port 18 and into chamber16 of pump bulb 14. The negative pressure within pump bulb 14 andconnected chambers can move reservoir poppet 28 in a way that breaks theseal between face seal portion 30 and valve seat 34. Fluid may then flowfrom the reservoir into annular channel 68, radial channel 70, 72, and74, and transfer chamber 22, past face seal portion 30, and into fluidpassageway 24. Any fluid under negative pressure within fluid passageway24 will move into chamber 16 of pump bulb 14 until chamber 16 is fulland/or there is no longer enough negative fluid pressure to keep faceseal portion 30 from moving toward valve seat 34. Spring 32 then causesreservoir poppet 28 to reseat itself against valve seat 34. At thispoint, the user may then squeeze or compress pump bulb 14 to again movefluid from pump bulb 14 into ports 20 and 21 and inflatable cylinders,as described above.

Under certain conditions, when pump bulb 14 is pulling or drawing fluidfrom the reservoir and through the various chambers of the system,negative fluid pressure may cause reservoir poppet 28 to move in a waywhere a seal can be formed between face seal portion 30 and flange 44.If such seal is formed, a situation might exist in which the negativepressure in pump bulb 14 prevents reservoir poppet 28 from moving towardvalve seat 34. This condition may prevent fluid from flowing from thereservoir to refill the pump bulb 14. If this occurs, some correctiveaction may be required such as may include at least some deflation ofthe cylinders before the inflation process can continue.

In order to provide a free path for fluid flow if reservoir poppet 28and flange 44 come into contact with each other during pump bulbrefilling, pump assembly 10 preferably includes a low flow fluid pathsuch as a vent or controlled leak or the like that permits some fluidflow from one side of flange 44 to the other side in the event that faceseal portion 30 is drawn into contact with flange 44. One configurationof such a fluid path is illustrated in FIGS. 10 and 11. In particular,FIG. 10 shows a cross-sectional view of pump assembly 76, which ispreferably similar to pump assembly 10 of FIG. 1. FIG. 11 shows across-sectional view of pump assembly 76 taken along the line 11-11 ofFIG. 10. Pump assembly 76 includes suction poppet 78 having face sealportion 80. Flange 82 is positioned within fluid passageway 84 andincludes protrusions 86, 88, and 90. As shown, protrusions 86, 88, and90 extend outwardly from flange 82 and are spaced apart around thecircumference of flange 82. In this way, if surface 92 is drawn intocontact with protrusions 86, 88, and 90, a gap is provided betweenflange 82 and face seal portion 80 that can allow for fluid flow throughthe gap. Such protrusions can be provided on flange 82, face sealportion 80, or both. This provides another fluid path between surface 92and flange 82. Any bumps, ridges, grooves, openings, channels, or thelike that function to allow fluid flow when surface 92 contacts flange82 can be used. For example, a small opening(s) such as a hole ororifice can be provided in one or both of flange 82 and face sealportion 80.

The sequence of filling pump bulb 14 under negative pressure and forcingthe fluid from pump bulb 14 under positive pressure may be repeated asmany times as necessary to achieve the desired inflation of thecylinders and/or to empty the connected reservoir. Once inflated, thefluid within the cylinders and ports 20 and 21 is under relatively highpressure. While poppet spring 38 preferably has a sufficiently strongbias to keep cylinder poppet 36 pressed against poppet valve seat 40,the relatively high pressure fluid in the cylinders and connectedchambers also pushes sealing surface 39 of face seal portion 37 ofcylinder poppet 36 into contact with sealing surface 41 of valve seat40, further strengthening this seal. This seal between cylinder poppet36 and valve seat 40 is particularly important to keep the cylindersinflated (i.e., to prevent undesirable transfer of fluid from thecylinders into fluid passageway 24). Because the only path for fluid tomove from ports 20 and 21 into fluid bypass chamber 46 is through fluidpassageway 24, it is likewise not possible for fluid from the cylindersto move into fluid bypass chamber 46 without first breaking the sealbetween cylinder poppet 36 and its poppet valve seat 40.

When the user desires to deflate the cylinders, the walls of pump body12 will be manually compressed in the general area of fluid passageway24. In order to assist the user in finding the proper area forcompression, the outer surface of pump body 12 may be provided withraised or otherwise detectable areas for easier determination of propermanipulation locations on the pump body 12. One example of such adetectable area is illustrated as a user pressure pad 66, which is araised surface portion on the side of pump body 12 that would bedetectable by the human fingers. A compressive force on pump body 12 atpressure pad 66 forces reservoir poppet 28 away from valve seat 34 by asufficient distance that face seal portion 30 moves toward cylinderpoppet 36 past flange 44. When the compressive force on pump body 12 isreleased, flange 44 then engages face seal portion 30 at chamfer 31 tohold reservoir poppet 28 in place against the bias of spring 32. Thiscompression of pump body 12 simultaneously moves nose portion 50 ofreservoir poppet 28 into contact with receiver 48 of cylinder poppet 36,which also breaks the seal between cylinder poppet 36 and poppet valveseat 40. Further, such pump body compression also causes reservoirpoppet 28 to be in a position where lip seal 42 is in contact withreservoir poppet 28, which provides a fluid tight seal between thesesurfaces. Fluid from the cylinders and connecting ports 20 and 21 maythen flow around cylinder poppet 36, past poppet valve seat 40, and intobypass input channel 62. Notably, a single compressive squeeze by theuser is sufficient to put pump assembly 10 in this cylinder deflationmode. In other words, there is no need for the user to continue to holdpump body 12 in this compressive condition while the cylinder deflationis occurring.

Once the fluid enters bypass input channel 62, it moves directly intofluid bypass chamber 46, where sufficient fluid pressure can unseat ball56 from ball valve seat 52 and allow fluid to move out of chamber 46through bypass output channel 64 and into fluid passageway 24. The fluidcan then move through annular channel 68, radial channels 70, 72, and74, and then into transfer chamber 22 to port 18, and then into thereservoir. Fluid also flows into an open space 75 that extends into thegeneral area of the pressure pad 66. Annular channel 68 and radialchannels 70, 72, and 74 are preferably designed to allow fluid to flowfrom fluid passageway 24 to transfer chamber 22 when pressure pad 66 isbeing compressed to activate the deflation mode and space 75 isminimized or eliminated by compression of pad 66. In this way, fluidflow will not be interrupted if compression of pressure pad 66 ismaintained.

Because the fluid within the cylinders before deflation is underrelatively high pressure, an initial volume of pressurized fluid willmove under pressure from ports 20 and 21 and into pump body 12 uponcompression of pump body 12. After this initial volume has beentransferred and the fluid has reached an equilibrium pressure, thecylinders may be manually compressed or manipulated to transfer theremainder of the fluid to the reservoir without the need to squeeze pad66 or hold the pump, thereby completely deflating the cylinders. Pumpassembly 10 is then configured again in its auto-inflation resistancemode, as described above.

FIG. 12 illustrates an embodiment of an implantable penile prosthesissystem 120 of the invention, which includes a pump of the typeillustrated in FIGS. 1 through 11, reservoir 122 that is separate frompump assembly 124, and cylinders 126. In general, this system 120utilizes pump assembly 124 and reservoir 122 to inflate cylinders 126,with connecting tubing attached between pump assembly 124 and bothreservoir 122 and cylinders 126. Pump assembly 124 can also be used todeflate the cylinders, as described above. Reservoir 122 is preferablyconstructed from a thick, high durometer elastomeric material, such assilicone and is specifically sized to hold a certain volume of fluidthat corresponds to at least the volume difference desired to expand thecylinders 126.

As shown, two tubes 128 extend from pump assembly 124, each of whichconnects to one of cylinders 126. A single tube 130 extends fromreservoir 122 for connection to pump 124. It is contemplated, however,that the number of tubes and the branching of tubes can differ from thisarrangement, depending on the design of the pump and other components.As described above relative to pump assembly 10, the body of pumpassembly 124 can be squeezed generally along its longitudinal axis inorder to deflate cylinders 126, which thereby opens certain valveswithin the pump and allows pressurized fluid from the cylinders to movethrough the pump and enter the reservoir. Inflation of the cylinders canbe accomplished by first squeezing the pump bulb to activate pumpassembly 124, then squeezing the pump bulb repeatedly until the desiredcylinder inflation is achieved.

The present invention has now been described with reference to severalembodiments thereof. The entire disclosure of any patent or patentapplication identified herein is hereby incorporated by reference. Theforegoing detailed description and examples have been given for clarityof understanding only. No unnecessary limitations are to be understoodtherefrom. It will be apparent to those skilled in the art that manychanges can be made in the embodiments described without departing fromthe scope of the invention. Thus, the scope of the present inventionshould not be limited to the structures described herein, but only bythe structures described by the language of the claims and theequivalents of those structures.

1. A pump for transferring fluid between a fluid reservoir and at leastone inflatable penile prosthesis, the pump comprising: a pump housinghaving a fluid passageway; first and second fluid ports in fluidcommunication with the fluid passageway and operatively connectable to afluid reservoir and at least one inflatable penile prosthesis,respectively; a pump bulb in fluid communication with the fluidpassageway that can be operated to transfer fluid between the first andsecond fluid ports through the fluid passageway; first and secondpoppets positioned within the fluid passageway, aligned along a valveaxis, and biased toward first and second valve seats within the fluidpassageway, respectively, wherein the first poppet comprises an endslidingly engaged with the second poppet and an extending portionextending away from a body portion of the first poppet; a flange spacedfrom the first valve seat within the fluid passageway and extending froma surface of the fluid passageway toward an interior area of the fluidpassageway; a first fluid path between the extending portion of thefirst poppet and the flange when the extending portion of the firstpoppet is in contact with the flange, wherein the first fluid path canallow fluid to pass from one side of the flange to the other; and asecond fluid path providing fluid communication between the fluidpassageway and a fluid bypass chamber when the extending portion of thefirst poppet is in contact with the first valve seat; wherein the fluidbypass chamber is fluidly connected by a bypass input channel to thefluid passageway at a first location and fluidly connected by a bypassoutput channel to the fluid passageway at a second location.